Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts
DILATE
Prospective, Open-Label, Multi-Center ProceDural Data CollectIon Case Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (The DILATE Registry)
1 other identifier
observational
200
1 country
16
Brief Summary
A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
March 25, 2025
CompletedStudy Start
First participant enrolled
April 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2027
May 27, 2026
May 1, 2026
1.8 years
February 3, 2025
May 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in target vessel diameter following NeVa VS use
Up to 1 hour post procedure
Study Arms (1)
Treatment Group
Interventions
Eligibility Criteria
subjects with cerebral vasospasm
You may qualify if:
- Age ≥22
- Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
- Vessel dilation procedure was performed with the NeVa VS
- Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vesaliolead
Study Sites (16)
Providence St. Joseph Medical Center
Burbank, California, 91505, United States
John Muir Health
Walnut Creek, California, 94589, United States
Yale
New Haven, Connecticut, 06520, United States
Baptist Health South Florida
Miami, Florida, 33143, United States
Wellstar Health System
Marietta, Georgia, 30062, United States
Endeavor Health
Evanston, Illinois, 60201, United States
Univ Iowa
Iowa City, Iowa, 52242, United States
Univ Kentucky
Lexington, Kentucky, 40506, United States
MaineHealth
Portland, Maine, 04102, United States
Mayo Clinic- Rochester
Rochester, Minnesota, 55905, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15222, United States
Geisinger
Wilkes-Barre, Pennsylvania, 18711, United States
Valley Baptist Medical Center- Harlingen
Harlingen, Texas, 78550, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Uni. of Utah
Salt Lake City, Utah, 84112, United States
West Virginia University
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2025
First Posted
March 25, 2025
Study Start
April 14, 2025
Primary Completion (Estimated)
February 14, 2027
Study Completion (Estimated)
March 15, 2027
Last Updated
May 27, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share